HD is caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries, according to the World Health Organization (WHO).
The NDA was based on positive results from two Phase-III trials, FIRST-HD and ARC-HD.
In the placebo-controlled, randomized FIRST-HD study, SD-809 reduced chorea in patients with HD, while positive top-line data from the ARC-HD trial showed that patients were able to safely convert from tetrabenazine to SD-809 overnight with continued control of chorea.
Teva Global R&D president and chief scientific officer Michael Hayden said: "The opportunity to bring a new treatment option to those battling the devastating illness of Huntington disease is an important first step and an indication of our profound commitment to improving the lives of patients with this and other debilitating movement disorders.
"With this filing and an ongoing investment in HD research, Teva has further established itself as a leader in the development of treatments focusing on movement disorders."
In November last year, SD-809 was granted FDA orphan drug designation to treat HD and became part of Teva’s CNS portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.